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EP2278925A1 - Dispositifs et procédés pour déployer des sutures médicales - Google Patents

Dispositifs et procédés pour déployer des sutures médicales

Info

Publication number
EP2278925A1
EP2278925A1 EP09729829A EP09729829A EP2278925A1 EP 2278925 A1 EP2278925 A1 EP 2278925A1 EP 09729829 A EP09729829 A EP 09729829A EP 09729829 A EP09729829 A EP 09729829A EP 2278925 A1 EP2278925 A1 EP 2278925A1
Authority
EP
European Patent Office
Prior art keywords
suture
anchoring element
needle
substantially hollow
deployment device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09729829A
Other languages
German (de)
English (en)
Inventor
Paul A. Talmo
Michael Lovuolo
Thomas A. Jellison
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP2278925A1 publication Critical patent/EP2278925A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0416—Packages or dispensers for suture anchors or for anchor applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0448—Additional elements on or within the anchor
    • A61B2017/0451—Cams or wedges holding the suture by friction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06176—Sutures with protrusions, e.g. barbs

Definitions

  • the invention generally relates to devices and methods for medical suturing. More particularly, the invention relates to devices and methods for quickly and safely deploying medical sutures for use, for example, in hernia or pelvic prolapse repair.
  • Urinary incontinence and pelvic prolapse are conditions that arise from hernias which have developed in the vagina and which result in the loosening of various structures.
  • the underlying structures such as, for example, the bladder, rectum, uterus, and small bowel
  • the underlying structures bulge into the vagina, causing the vaginal skin to prolapse.
  • Various terms (such as, for example, cystocele, rectocele, uterine prolapse, and enterocele) are used to describe which of the underlying structures are prolapsing.
  • hernia develops when the outer layers of the abdominal wall weaken, bulge, or actually rip. The hole in this outer layer allows the inner lining of the cavity to protrude and to form a sac. Any part of the abdominal wall can develop a hernia.
  • the most common site for hernias is the groin (i.e. an inguinal hernia).
  • the suture deployment devices and methods described herein may enable hernia or prolapse repair procedures, and other appropriate medical procedures, to be done faster, quicker, and safer. They may also allow potential migration of these invasive procedures, which are currently being performed in the operating room under anesthesia, to a completely non-invasive office- based procedure, wherein no incision is necessary.
  • the present invention may provide a suture and a suture deployment device, and associated methods of use.
  • the invention allows for the pinpoint attachment of a support element through minimal incisions with greater safety, speed, and efficacy.
  • such devices and methods may be easily and consistently operated by a user and provide a broad-based flexibility for use in various other medical applications.
  • One aspect of the invention includes a medical suture.
  • the medical suture may include an elongate suture wire, a first anchoring element connected to a first end of the elongate suture wire, and a second anchoring element connected to a second end of the elongate suture wire.
  • the elongate suture wire may include a material selected from the group consisting of a polymer, a metal, a plastic, a fabric, and combinations thereof.
  • the polymer may be an absorbable polymer, such as, but not limited to, an absorbable polylactic acid (PLA) or an absorbable polyglycolic acid (PGA).
  • the polymer may be nylon or polypropylene.
  • at least one of the first anchoring element and the second anchoring element may include a T-bar element.
  • At least one of the first anchoring element and the second anchoring element may include a material selected from the group consisting of a polymer, a metal, a plastic, a fabric, and combinations thereof.
  • the metal may, for example, include stainless steel, aluminum, titanium, nickel-titanium, cobalt-chromium, and/or platinum.
  • at least one of the first anchoring element and the second anchoring element may include a hole, with the elongate suture wire extending through at least a portion of the hole.
  • the suture deployment device may include a housing and a substantially hollow elongate needle including a slot extending along a length thereof.
  • the substantially hollow elongate needle may be coupled at a proximal end to the housing.
  • the distal end of the substantially hollow elongate needle may include a sharpened tip for piercing tissue.
  • the suture deployment device may include a suture storage cartridge coupled to the housing and adapted to load a suture anchoring element into the proximal end of the substantially hollow elongate needle and a push rod adapted to retractably extend through the substantially hollow elongate needle and eject a loaded suture from a distal end of the substantially hollow elongate needle when extended.
  • the suture deployment device may also include a deployment mechanism for retractably extending the push rod though the substantially hollow elongate needle.
  • the substantially hollow elongate needle may include a reinforced proximal portion.
  • the substantially hollow elongate needle may include a curvature along a longitudinal extent thereof.
  • the slot may be adapted to provide a channel for passing at least a portion of an elongate suture wire during ejection of the suture.
  • the suture storage cartridge is releasably coupled to the housing.
  • the substantially hollow elongate needle and the suture storage cartridge are coupled together, and are jointly releasably coupled to the housing.
  • the suture storage cartridge includes a spring mechanism.
  • the suture storage cartridge may be adapted to load a suture anchoring element into the proximal end of the substantially hollow elongate needle when the push rod is retracted into the housing.
  • the suture storage cartridge may be adapted to hold a plurality of suture anchoring elements.
  • the suture storage cartridge is loaded through the substantially hollow elongate needle.
  • the suture storage cartridge includes a preloaded, disposable cartridge.
  • the deployment mechanism includes a triggering mechanism.
  • the triggering mechanism may include at least one of a spring mechanism, a gear mechanism, a lever mechanism, a magnetic mechanism, a hydraulic mechanism, and an electrical mechanism.
  • the electrical mechanism may, for example, include a motor.
  • the triggering mechanism is manually actuated.
  • the device may include one or more optical fibers having a distal end(s) located adjacent the distal end of the needle to allow for visualization of the treatment area, for example, where visual access to the treatment site is otherwise compromised.
  • the device may include clips or other mechanical fasteners for attaching the optical fiber(s) to the device. The clips could be disposed at various locations along the device housing and/or needle as necessary.
  • Another aspect of the invention may include a method of deploying a suture.
  • the method may include the steps of providing a suture comprising a first anchoring element and a second anchoring element, with an elongate suture wire extending therebetween, and providing a suture deployment device including a substantially hollow elongate needle.
  • the methods may also include deploying the first anchoring element into a first location of a treatment site of a patient through the substantially hollow elongate needle, deploying the second anchoring element into a second location of the treatment site through the substantially hollow elongate needle, cutting the elongate suture wire extending between the first anchoring element and a second anchoring element to create two elongate suture wire portions, and tying the two elongate suture wire portions together to anchor the first anchoring element and a second anchoring element.
  • the method further includes loading the suture into the suture deployment device prior to deployment.
  • the suture deployment device may include a triggering mechanism.
  • the step of deploying the first anchoring element may include inserting a distal end of the substantially hollow elongate needle into the treatment site at a first location and actuating the triggering mechanism to eject the first anchoring element from the distal end of the substantially hollow elongate needle.
  • the step of deploying the second anchoring element may include removing the distal end of the substantially hollow elongate needle from the treatment site, inserting the distal end of the substantially hollow elongate needle into the treatment site at a second location, and actuating the triggering mechanism to eject the second anchoring element from the distal end of the substantially hollow elongate needle.
  • the treatment site may include a hernia or a region of pelvic prolapse.
  • the method may further include the step of placing a support element within the treatment site.
  • the support element may, for example, include a patch for an urethrovesical suspension or ventral hernia procedure. At least one of the first anchoring element and second anchoring element may be deployed along a circumference of the support element.
  • FIG. IA is a schematic side view of a suture with two anchoring elements, in accordance with one embodiment of the invention.
  • FIG. IB is a schematic side view of another suture with two anchoring elements, in accordance with one embodiment of the invention.
  • FIG. 1C is a schematic side view of a suture with a barbed anchoring element joining two separated sections of a body part, in accordance with one embodiment of the invention
  • FIG. ID is a schematic side view of a suture with a plurality of anchoring elements deployed in a treatment site, in accordance with one embodiment of the invention
  • FIG. 2A is a schematic end view of an anchoring element for a suture, in accordance with one embodiment of the invention.
  • FIG. 2B is a schematic side view of the anchoring element of FIG. 2A;
  • FIG. 2C is a schematic sectional view of the anchoring element of FIG. 2A, through the line C — C of FIG. 2A, with a suture inserted;
  • FIG. 3A is a schematic end view of an anchoring element for a suture, in accordance with one embodiment of the invention.
  • FIG. 3B is a schematic side view of the anchoring element of FIG. 3A;
  • FIG. 3C is a schematic sectional view of the anchoring element of FIG. 3A, through the line C — C of FIG. 3A, with a suture inserted;
  • FIG. 4A is a schematic end view of an anchoring element for a suture, in accordance with another alternative embodiment of the invention.
  • FIG. 4B is a schematic side view of the anchoring element of FIG. 4A;
  • FIG. 4C is a schematic sectional view of the anchoring element of FIG. 4A, through the line C — C of FIG. 4A, with a suture inserted;
  • FIG. 5A is a schematic end view of an anchoring element for a suture, in accordance with another alternative embodiment of the invention.
  • FIG. 5B is a schematic side view of the anchoring element of FIG. 5A;
  • FIG. 5C is a schematic sectional view of the anchoring element of FIG. 5A, through the line C — C of FIG. 5A, with a suture inserted;
  • FIG. 6A is a schematic side view of a substantially hollow needle for a suture deployment device, in accordance with one embodiment of the invention.
  • FIG.6B is a schematic top view of the hollow needle of FIG. 6A;
  • FIG. 6C is a schematic side view of another substantially hollow needle for a suture deployment device, in accordance with one embodiment of the invention;
  • FIG.6D is a schematic sectional top view of the substantially hollow needle of FIG.
  • FIG. 7 is a schematic sectional side view of a hollow needle and suture loading element, with a suture loaded therein, in accordance with one embodiment of the invention.
  • FIG. 8A is a schematic side view of a suture deployment device, in accordance with one embodiment of the invention.
  • FIG. 8B is a schematic end view of the suture deployment device of FIG. 8A, with a suture loaded therein;
  • FIG. 8C is a schematic side view of the suture deployment device of FIG. 8A, with a suture loaded therein;
  • FIG. 8D is a schematic sectional view of the suture deployment device of FIG. 8A through the line D — D of FIG. 8B, prior to deployment of a suture anchoring element;
  • FIG. 8E is a schematic sectional view of the suture deployment device of FIG. 8 A through the line D — D of FIG. 8B, during deployment of a suture anchoring element;
  • FIG. 8F is a schematic sectional view of the suture deployment device of FIG. 8A through the line D — D of FIG. 8B, with a plurality of sutures loaded therein;
  • FIGS. 9A-9I show a method of deploying a suture using a suture deployment device, in accordance with one embodiment of the invention.
  • FIG. 10 is a schematic sectional side view of a suture deployment device, in accordance with another alternative embodiment of the invention.
  • FIG. 11 is a schematic sectional side view of a suture deployment device, in accordance with another alternative embodiment of the invention.
  • FIG. 12 is a schematic sectional side view of a suture deployment device, in accordance with another alternative embodiment of the invention.
  • FIG. 13 is a schematic sectional side view of a suture deployment device, in accordance with another alternative embodiment of the invention.
  • FIG. 14 is a schematic sectional side view of a suture deployment device, in accordance with another alternative embodiment of the invention.
  • the present invention relates to methods and devices of deploying medical sutures, for example in urethrovesical suspension procedures, or other appropriate surgical techniques involving the deployment of sutures with anchoring elements.
  • suture deployment devices have many potential uses in the placement of a suburethral sling, which vary according to where the suture anchoring elements are anchored. Once a suture anchoring element is deployed, the attached suture or mesh may be used to create a sling or hammock support underneath the urethra.
  • An example procedure for anchoring a support describing the placement of an anchoring element in the traditional position above the rectus fascia, is described in U.S. Patent No. 6,595,911, the disclosure of which is hereby incorporated herein by reference in its entirety.
  • Suture deployment devices may also be similarly used in the surgical repair of a hernia.
  • the methods and devices described herein may be used to form a mini-sling where the suture anchoring elements are guided on either side of the bladder neck upwards but stopped prior to penetrating the rectus fascia.
  • the suture anchoring elements may then be deployed in the fatty fibrous tissue, which lies beneath the rectus fascia but can still provide support. This would allow greater safety with reduced probability of bladder injury, bleeding, or nerve damage.
  • Another embodiment of the invention may include a procedure for the preparation of a pre -pubic sling, where the toggle device is inserted into the vagina, but rather than going behind the pubic bone goes in front of the pubic bone.
  • the suture anchoring elements may then be deployed into the muscle tissue just underneath the skin.
  • the suture anchoring elements may be attached to a mesh or a suture, which could then be used to anchor any type of tissue underneath the bladder neck creating a sling/hammock.
  • the suture deployment device may allow the procedure to be performed through smaller incisions, which potentially may allow this procedure to be performed in a medical office setting, rather than in a surgical theater.
  • the pre-pubic approach has the advantage of not passing the needle through the retropubic space (behind the pubic bone), which could then risk bladder, bowel, or blood vessel injury.
  • Another embodiment of the invention may include a procedure for hernia repair or pelvic prolapse repair using a vault suspension, where the suture deployment device may be used to deploy sutures in a variety of structures lying high up in the pelvic region. Once the suture anchoring elements are placed, the attached suture may be used to anchor soft tissue or mesh/biologic graft for prolapse repair.
  • the anchor may be deployed in a variety of support structures including the sacrospinous ligament, coccygeus muscle or arcus tendineus facia; all strong support structures that create high suspension of the vagina.
  • One example method of using the invention may include performing prolapse repair procedures without the need for a vaginal incision.
  • One embodiment of the invention includes a medical suture with an anchoring element, such as, but not limited to, a T-bar, at each end.
  • An example suture 100 is shown in FIG. IA.
  • the suture 100 includes a suture wire 110 with an anchoring element 120 attached at each end.
  • the suture wire 110 may be of any appropriate length necessary to carry out the specific medical procedure of interest.
  • the suture wire 110 may range from approximately 50mm to 300mm, and more particularly from 100mm to 200mm.
  • the suture wire 110 may, in one embodiment, have a diameter ranging from 0.3mm to 3mm, as appropriate.
  • the suture wire 110 may include distal portions of a first diameter, with a central portion of a different diameter.
  • a suture 150 includes two anchoring elements 120, with a suture wire 130 including thin end portions 140, with a thicker central portion 150. This thicker central portion may, for example, be advantageous in easing the manufacture of a suture wire, such as a suture wire manufactured using an injection molding technique.
  • the suture wire 110 and/or anchoring elements 120 may be manufactured from a material including a metal, a plastic, a polymer, a textile, a composite material, or combinations thereof.
  • the suture wire 110 and anchoring elements 120 are both constructed from an absorbable material, such as, but not limited to, an absorbable polylactic acid (PLA), polyglycolic acid (PGA), or combinations thereof.
  • at least one of the suture wire 110 and/or anchoring elements 120 may be constructed from a permanent material such as, but not limited to, polypropylene, titanium, aluminum, or stainless steel.
  • the suture wire 110 and anchoring elements 120 may be constructed from the same material, or from different materials. In one embodiment, both the suture wire 110 and anchoring elements 120 are constructed as a one piece molded unit from a resorbable material. In an alternative embodiment, the suture 110 may be constructed as a two, or more, piece insert molded structure. This would allow for two different hardness materials to be used for suture wire 110 and anchoring elements 120.
  • the suture 100 may include two anchoring element 120, one at each end of the suture wire 110.
  • additional anchoring elements 120 may be placed along the length of the suture wire 110, thereby allowing a single suture 100 to be anchored at more than two locations.
  • the suture 100 may only have an anchoring element 120 at one end, or have differently shaped and/or configured anchoring elements 120 at each end.
  • the anchoring elements 120 may be slightly curved and/or flexible in order to allow them to pass through a curved needle of a deployment device.
  • the anchoring elements 120 at each end of the suture wire 110 may be of the same size and material, or different sized and materials, as appropriate.
  • the anchoring elements may have a diameter ranging from approximately lmm to 3mm, and an elongate length ranging from approximately 5mm to 25mm.
  • one or more anchoring elements may include a barbed portion.
  • the barbed end portions 170 may, for example, allow the anchoring element 160 to be placed between two separated sections of a body part 180, such as, but not limited to, a bone, a tendon, or other appropriate body part, and provide an anchoring means to rejoin these separated sections 180.
  • a suture wire 110 may be connected to a plurality of anchoring elements 120, with, for example, an anchoring element 120 located at each end of the suture wire 110, and additional anchoring elements 125 positioned at discrete intervals along the length of the suture wire 110.
  • the suture 190 is shown with the anchoring elements 120, 125 deployed within a treatment site and inserted through tissue 192 and a support element 194. A method of deploying a suture is described below for FIGS. 9 A to 91.
  • the suture 190 may include any number of anchoring elements 125, as required.
  • the anchoring elements 120 may be attached to the suture wire 110 by any appropriate means, such as, but not limited to, a mechanical connection, such as crimping or tying, or by bonding.
  • Example anchoring elements are shown in FIGS. 2A-5C.
  • the anchoring element 120 shown in FIGS. 2A-2C includes a solid elongate shaft 210 with a hole 220 drilled through a central portion 230 to provide an attachment location for the suture wire 110.
  • a distal end of the suture wire 110 may be passed through the hole 220 and crimped, thereby forming a thicker end portion of the suture wire 110 that may be securely fitted within the hole 220.
  • a separate crimping element 250 may be crimped onto the suture wire 110.
  • the separate crimping element may, for example, include a ring, a ball, a cylinder, a sleeve, a sheet or other appropriate element, and may be manufactured from a material including, but not limited to, a metal (such as stainless steel or aluminum), a plastic, and/or a fabric.
  • the crimping element may be of any appropriate length necessary to provide a sufficient bond between the suture wire 110 and anchoring element 120.
  • the suture wire 110 may be folded over at its distal end and crimped to itself.
  • the crimped wire portion may be bonded to at least a portion of the walls of the hole 220 to further secure the anchoring element 120 to the suture wire 110.
  • the crimped portion may be secured within the hole 220 through a simple pressure fitting.
  • the anchoring element 120 may include rounded distal ends 240 in order to ensure that the anchoring element 120 is atraumatic (i.e. to prevent the ends from cutting or otherwise harming any tissue or other body substance that it touches).
  • Alternative configurations of anchoring element 120 are shown in FIGS. 3A-5C. The anchoring element 120 shown in FIGS.
  • 3A-3C includes a solid elongate shaft 310 with a cutout section 320 extending along a central portion 330 of the solid elongate shaft 310.
  • a first hole 340 extends through the central portion 330 of the anchoring element 120 and into the cutout section 320, with a second hole 350 extending back through the solid elongate shaft 310 at a distal end 360 of the cutout section 320.
  • the second hole 350 is not included, with only the first hole 340 extending into the cutout section 320.
  • the suture wire 110 may be bonded or otherwise attached to the anchoring element 120 through the holes 340, 350 and cutout section 320, as appropriate.
  • the suture wire 110 may be bonded to the anchoring element 120 by any appropriate bonding, such as, but not limited to, adhesive bonding, welding, and/or heat bonding.
  • the anchoring element 120 shown in FIGS. 4A-4C includes a solid elongate shaft 410 with a elongate hole 420 extending along a central axis 450 of the solid elongate shaft 410.
  • a hole 440 extends through the central portion 430 of the anchoring element 120 and into the elongate hole 420, thereby providing a location for the attachment of a distal end of the suture wire 110 through crimping, bonding, and/or any other appropriate means.
  • the elongate hole 420 may be a stepped hole, thereby providing an abutment location for the crimped portion to rest against, and preventing slippage of the suture wire 110.
  • the anchoring element 120 shown in FIGS. 5A-5C includes a hollow elongate shaft 510 with a hollow interior 520 extending along a central axis 550 of the solid elongate shaft 510.
  • a hole 540 extends through the central portion 530 of the anchoring element 120 and into the hollow interior 520, thereby providing a location for the attachment of a distal end of the suture wire 110 through crimping, bonding, and/or any other appropriate means.
  • other appropriate means of fixedly or removably attaching the anchoring elements 120 to the distal ends of the suture wire 110 may be used, as appropriate.
  • the suture 100 may be inserted into a target location of a body to provide any one of a number of medical functions.
  • the suture 100 may be used to close a wound or surgical incision in a patient, or secure an internally and/or externally placed support element, or other medical treatment element or device.
  • one or more sutures 100 are used to anchor a support element, such as, but not limited to, an urethrovesical suspension procedure.
  • the anchoring elements may be deployed around at least a portion of a circumference of the support element.
  • the anchoring elements 120 of a suture 100 may be deployed through a substantially hollow elongate needle and into a treatment location of a patient.
  • An example hollow elongate needle 600 for use in deploying a suture 100 is shown in FIGS. 6A-6B.
  • the needle 600 includes a proximal end 610, for attaching to a housing of a suture deployment device, and a distal end 620 for insertion into a treatment site of a patient.
  • the needle may, in one embodiment, include a slot 630, such that while an anchoring element 120 is passed through the hollow central extent of the needle 600, the suture wire 110 is free to extend out through the slot 630 and thereby be free of the needle upon deployment of the anchoring elements 120. This allows a suture 100 with anchoring elements 120 at each end to be deployed easily without the suture wire 110 remaining within the needle 600 during deployment of the second anchoring element 120 and thereby blocking the deployment of the second anchoring element 120.
  • the distal end of the needle 600 includes an angled tip portion 640, which can be used to pierce the boundary of the treatment site, such as, but not limited to, the skin or other body portion of the patient, to allow the needle to be extended into the treatment site.
  • the anchoring elements may then exit the needle 600 through a deployment port 650 in the tip portion 640.
  • the needle 600 may include a reinforced section to strengthen the needle 600 during piercing of the treatment site boundary. This reinforced section may include a region of thicker needle material, a reinforcing sleeve, or another appropriate strengthening means.
  • the needle 600 may, in one embodiment, be reinforced at a distal end, a proximal end, and/or a central portion.
  • the angle of the tip portion 640 may be set at any appropriate angle to allow it to safely and easily pierce the boundary of the treatment site, and may be sharper of blunter than the angle shown in FIG. 6 A and 6B, as appropriate.
  • the needle may be of any appropriate dimensions necessary to carry appropriately sized suture anchoring elements 120 and extend into appropriate body regions.
  • the needle 600 may have an outer diameter ranging from approximately l-3mm, and a length ranging from approximately 20- 100mm.
  • the needle 600 may have a consistent wall thickness along a length thereof.
  • the wall thickness of the needle may vary along the length of the needle 600.
  • the inner and/or outer diameter of the needle 600 may vary along a length thereof.
  • the needle 600 may be curved along at least a portion of its longitudinal extent. As a result, the needle 600 may be inserted into the treatment site of a patient along a curved trajectory, thereby allowing an anchoring element 120 to be inserted at an angle and/or allowing the needle 600 to avoid an obstruction when entering the treatment location.
  • the hollow interior surface of the needle 600 may include a low friction material to ease the travel of the anchoring elements 120 and/or push rod.
  • the needle 600 includes a substantially solid tip portion 640, with a deployment port 650 located at the distal end 620 of the needle 600 behind the tip portion 640. An example needle 600 including a solid tip portion 640 is shown in FIGS.
  • an anchoring element 120 may be passed through the hollow central extent of the needle 600 with the suture wire 110 free to extend out through the slot 630, as described above. Upon reaching the distal end 620, the anchoring element 120 passes from the needle 600 through the deployment port 650 and into a treatment site.
  • the deployment port 650 may be located at any position along the elongate length of the needle 600.
  • the edges of the deployment port 650 do not impinge directly on the tissue through which the needle 600 is passed, and therefore do not apply additional trauma to the tissue beyond that applied by the tip portion 640 itself.
  • the tip portion 640 may, in certain embodiments, include curved edges, or other shaped elements, to further reduce the trauma on the tissue.
  • the needle 600 may be mounted at its proximal end 610 to a suture storage cartridge 700. A sectional side view of the example needle 600 and suture storage cartridge 700 through the central axis of the needle can be seen in FIG. 7.
  • the suture storage cartridge 700 may be used to store anchoring elements 120 for one or more sutures 100 in a preferred orientation, and load the anchoring elements 120 sequentially and one at a time into the needle 600 ready for deployment.
  • the suture storage cartridge 700 includes a spring-loaded mechanism 710, including a spring 720, housed within a storage cartridge housing 730.
  • the storage cartridge housing 730 is adapted to hold a plurality of suture anchoring elements 120 such that the spring 720 preferentially forces a single anchoring element 120 into the proximal end 610 of the needle 600 when it is empty.
  • a ratchet mechanism may be used to preferentially force anchoring elements 120 into the proximal end 610 of the needle 600 when it is empty.
  • the storage cartridge housing 730 may be configured to hold any number of suture anchoring elements, as required.
  • the storage cartridge housing 730 may include a slot 750 (shown in FIGS. 8 A and 8C) in communication with the needle slot 630, allowing the suture wires 110 to extend clear of the device and thereby avoid blocking the deployment of the anchoring elements 120.
  • the storage cartridge housing 730 and needle 600 may be permanently attached to a housing of a suture deployment mechanism for deploying the anchoring elements 120.
  • the storage cartridge housing 730 and/or needle 600 may be modularly designed so that it may be removed from the housing of the suture deployment mechanism and replaced with newly loaded cartridge 730 and fresh sharp needle 600.
  • anchoring elements 120 may be loaded into the storage cartridge housing 730 through the hollow elongate needle 600. In an alternative embodiment, anchoring elements 120 may be loaded into the storage cartridge housing 730 through a separate loading passageway within the storage cartridge housing 730. In a further alternative embodiment, the storage cartridge housing 730 may be loaded with anchoring elements 120 prior to being coupled to the needle 600 and/or deployment device.
  • the anchoring elements 120 may be deployed by a push rod 740.
  • This push rod 740 may be extended and retracted in a reciprocating motion. For example, at rest, the push rod 740 may be positioned in a retracted position.
  • the multiple anchoring elements 120 for the sutures 100 may be loaded, one at a time, into the needle 600 by the spring-loaded mechanism 710.
  • a suture deployment device i.e. a suture tagging device
  • the push rod 740 when the push rod 740 is extended into the needle 600, it blocks the suture storage cartridge 700 and prevents additional anchoring elements 120 from being inserted into the needle 600.
  • the push rod 740 may be manufactured from a metal, a plastic, or any other appropriate material.
  • the push rod 740 is manufactured from nickel-titanium (NitinolTM).
  • the suture deployment device may deploy a suture anchoring element 120 by actuating the push rod 740 to extend through the hollow elongate needle 600.
  • This actuation may be achieved through a mechanical actuation mechanism, an electrical actuation mechanism, a magnetic actuation mechanism, a hydraulic actuation mechanism, or a combination thereof.
  • the actuation mechanism may be manually actuated and/or be automatically actuated in response to an instruction from a control device.
  • the actuation mechanism is a mechanical trigger mechanism. This trigger mechanism advances the distal end of push rod 740 through the hollow elongate needle 600, thereby pushing a single anchoring element 120 through and out of the distal end of the needle 600.
  • the push rod 740 pushes the first anchoring element 120 from out of the needle 600 and into the treatment site.
  • the push rod 740 returns to its original retracted position, allowing another suture anchoring element 120 to be loaded into the hollow elongate needle 600 and thereby preparing the device for deployment of another suture anchoring element 120.
  • FIGS. 8A-8F An example suture deployment device including a triggering mechanism is shown in FIGS. 8A-8F.
  • the suture deployment device 800 includes a housing 805 including a handle element 810, with a triggering mechanism 815 held therein.
  • a suture storage cartridge 700 and a needle 600 are mounted to the housing 805 such that in operation, actuation of the triggering mechanism results in the deployment of a suture anchoring element 120 from the distal end 620 of the needle 600.
  • the triggering mechanism 815 includes a pivoting mechanism adapted to extend and retract a push rod 740 through the needle 600 upon actuation.
  • the triggering mechanism 815 includes a user interface element 820 (in this case a trigger) that pivots about a pivot point 830.
  • a pivoting lever mechanism 840 is coupled to the user interface element 820 and the push rod 740 such that, upon a pivoting of the user interface element 820 about the pivot point 830, the push rod 740 is forced along a track 850 such that its distal end extends through the hollow elongate needle 600.
  • the anchoring element 120 is pushed from the distal end 620 of the needle 600 and into the treatment site.
  • FIG. 8E A schematic sectional view of an example triggering mechanism 815 with the push rod 740 extended is shown in FIG. 8E.
  • the pivoting lever mechanism 840 includes a spring element 860 that is adapted to provide a restoring force to the user interface element 820, thereby returning the triggering mechanism 815 to its "at rest” position where the push rod 740 is fully retracted into the housing 805.
  • a schematic sectional view of an example triggering mechanism 815 with the push rod 740 retracted (i.e. in an "at rest” position) is shown in FIG. 8D.
  • the suture storage cartridge 700 is free to load another anchoring element 120 into the proximal end 610 of the needle 600, thereby placing the suture deployment device 800 in condition to deploy another anchoring element 120.
  • FIG. 8F A schematic sectional view of an example suture deployment device 800 with the a plurality of anchoring elements 120 for a plurality of sutures 100 loaded within the suture storage cartridge 700 is shown in FIG. 8F.
  • FIGS. 9A-9I An example method of performing a hernia or prolapse repair procedure to secure a support element to a treatment site of a patient is shown in FIGS. 9A-9I.
  • a support element 920 is first inserted into a first access location 910 of the treatment site and positioned against the relevant tissue 930.
  • the suture deployment device 800 can then be positioned outside the body at the treatment site, with the triggering mechanism 815 in an "at rest" position, as shown in FIG. 9A.
  • the needle 600 may be pushed through the tissue 930 and support element 920 so that the sharpened distal end 620 of needle 600 extends into the first access location 910 beyond the support element 920, as shown in FIG. 9B.
  • the triggering mechanism 815 may be actuated to force the push rod 740 through the needle 600, thereby pushing a first anchoring element 120 of a suture 100 out of the distal end 620 of the needle 600 and into the first access location 910, as shown in FIG. 9C.
  • the needle 600 can be retracted from the first access location 910, leaving the anchoring element 120 in place against the support element 920, with the suture wire 110 extending through the support element 920 and tissue 930 and back to the second anchoring element 120 still stored within the suture deployment device 800.
  • the suture wire 110 is free to extend out from the suture deployment device 800 through the needle slot 630 and the suture storage cartridge slot 750, the suture wire 110 will not have to pass through the needle 600. The suture wire will, therefore, not block or affect the deployment of the second anchoring element 120.
  • the needle 600 can be inserted through the tissue 930 and support element 920 and into a second access location 940 of the treatment site, as shown in FIG. 9D.
  • the second anchoring element 120 can then be deployed through the needle 600 and into the second access location 940 by triggering of the triggering mechanism 815 of the suture deployment device 800, as shown in FIG. 9E.
  • the suture deployment device 800 may be removed, as shown in FIG. 9F. Once the suture deployment device 800 has been removed, the suture wire 110 may be cut at a central portion 960, as shown in FIG. 9G.
  • the two separate suture wire section 970, 980 (each extending to an anchoring element 120 anchoring the support element 920 within the treatment site) can then be tightly tied together, as shown in FIGS. 9H and 91, thereby anchoring the support element 920 firmly and tightly against the tissue 930.
  • a knot 990 has been tied in the wire sections 970, 980, the free ends of the wire sections 970, 980 may be cut, thereby tidying up the treatment site. This procedure may be repeated at a plurality of locations around a circumferential edge of a support element 920 to anchor it firmly to the tissue 930 over its full extent and thereby provide support for the treatment site.
  • the suture wire 110 extends between the two anchoring elements 120 outside the body, a surgeon may insert a number of these sutures 100, according to the method of FIGS. 9 A to 91 for example, without fear of losing a suture 100 within the body. More particularly, in one embodiment of the invention, the step of cutting and tying the suture wire 110 to anchor the suture 100 tightly against the support element 920 and relevant tissue 930 may be performed after anchoring elements 120 for a plurality of sutures 100 have been deployed, thereby making the deployment of these sutures 100, quicker, more efficient, and safer.
  • the suture deployment device 800 may be loaded with multiple sutures 100 so that this procedure can be performed repeatedly without reloading the suture deployment device 800.
  • a support element 910 can be anchored at numerous locations quickly and safely.
  • a push rod may be actuated by any appropriate mechanical, electronic, and/or magnetic mechanism.
  • a gear mechanism such as, but not limited to, a rack and pinion gear mechanism, may be used to drive a flexible push rod.
  • the pivoting lever mechanism 840 of a suture deployment device 1000 may be replaced by a gear section 1010 and toothed rack 1020, as shown in FIG. 10.
  • FIG. 11 shows a suture deployment device 1100 with a gear train mechanism 1110.
  • actuation of a pivoting user interface element 1120 about a first pivot point 1130 causes the gear train mechanism 1110 to push a flexible push rod 1140 through the needle 600, thereby deploying an anchoring element 120.
  • the flexible push rod 1140 may pass through a number of guiding elements 1150 that are positioned to ensure a smooth extension of the flexible push rod 1140 into the needle 600.
  • a spring element may be added to preferentially force the push rod 1140 towards an "at rest" retracted position.
  • the push rod 1140 may be constructed from a metal, a plastic, or any other appropriate material.
  • the push rod 740 is constructed from NitinolTM.
  • FIG. 12 An alternative embodiment of the invention, with a suture deployment device 1200 including an alternative gear train mechanism 1210, is shown in FIG. 12.
  • the suture deployment device 1200 also includes a curved hollow elongate needle 1220, allowing the anchoring element 120 to be deployed along a curved path, for example to avoid an obstruction when entering the treatment location.
  • the needle 1220 may be curved in any direction, as appropriate.
  • the angle of curvature of the needle 1220 may range from 0° to 90°.
  • the angle of curvature of the needle may range from 30° to 75°.
  • the anchoring elements 120 (which may themselves be flexible, curved, and/or treated with a low friction material to ease passage through the curved needle 1220) may be deployed through a wide range of curved needle geometries, as required.
  • the needle 1220 may include a curvature control element, thereby allowing the needle 1220 to be set to a required curvature for each deployment procedure and/or by guidably curved during insertion into a treatment site.
  • the needle may include a flexible portion to facilitate the bending of the needle in a set direction, and/or to allow a user to adjustably set the needle at a specific angle prior to insertion into a treatment site, or guide the needle during insertion.
  • FIG. 13 A further alternative embodiment of the invention, with a suture deployment device 1300 including an alternative gear train mechanism 1310 coupled to a linearly moving user interface element 1320, is shown in FIG. 13.
  • gear train mechanism 1310 coupled to a linearly moving user interface element 1320
  • FIG. 13 A further alternative embodiment of the invention, with a suture deployment device 1300 including an alternative gear train mechanism 1310 coupled to a linearly moving user interface element 1320, is shown in FIG. 13.
  • other appropriate gearing mechanisms may be used, including larger and/or smaller components, as appropriate.
  • one or more gears may be manufactured from a material including, but not limited to, a plastic, a metal, a composite material, and combinations thereof.
  • the flexible push rod may be may constructed from a material that has sufficient strength and rigidity to maintain appropriate column strength to overcome spring pressures from a suture loading mechanism and drive an anchoring element 120 through the needle 600 and into a treatment site.
  • the flexible push rod may be made of a plastic, a metal, a composite material, and combinations thereof. More particularly, in one example embodiment, the flexible push rod may be manufactured from a nylon coated stainless steel wound cable, a NitinolTM coiled member, or any other appropriate material.
  • the actuation of the push rod may be performed through a smooth reciprocation motion or through a step motion including a number of deployment stages or levels.
  • the push rod may be actuated by a stepper motor or micro-motor, such as, but not limited to, a PortescapTM 2OD AM-L Digital Linear Actuator (which is a non-captive version of a micro-motor), available from Danaher Motion Portescap at 110 Westtown Road, West Chester, PA 19382.
  • a micro-motor allows for smaller and differently shaped suture deployment devices that do not, for example, require a pistol-type grip.
  • An example suture deployment device including a micro-motor is shown in FIG. 14.
  • the 14 may include a suture deployment device 1400 including a motor 1410 with a user control interface 1420.
  • the user control interface 1420 may include one or more buttons, switches, toggles, sliding elements, touch screen elements, or any other appropriate electromagnetic motor control interface element.
  • the motor 1410 may be connected through a drive shaft 1430 to a push rod 1440, such that actuation of the motor 1410 drives the push rod 1440 through the needle 600 in response to control signals from the user control interface 1420.

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  • Health & Medical Sciences (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
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Abstract

L'invention concerne une suture médicale (100) et des dispositifs et procédés pour déployer une suture médicale. Un mode de réalisation de l'invention concerne un dispositif de déploiement de suture (800) et un procédé d'utilisation, les dispositifs de déploiement de suture comprenant un logement (805), une aiguille (600) allongée sensiblement creuse, une cartouche de stockage (700) de la suture, une tige de poussée (740) conçue pour s'étendre de manière rétractable dans l'aiguille allongée creuse, et un mécanisme de déploiement (815) pour l'extension rétractable de la tige de poussée dans l'aiguille allongée creuse, la tige de poussée étant conçue pour éjecter une suture chargée depuis une extrémité distale de l'aiguille allongée creuse lorsqu'elle est étendue.
EP09729829A 2008-04-09 2009-04-09 Dispositifs et procédés pour déployer des sutures médicales Withdrawn EP2278925A1 (fr)

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US4356108P 2008-04-09 2008-04-09
PCT/US2009/040024 WO2009126781A1 (fr) 2008-04-09 2009-04-09 Dispositifs et procédés pour déployer des sutures médicales

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WO2009126781A1 (fr) 2009-10-15

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